Medical devices and methods useful for applying bolster material

ABSTRACT

Described are medical devices useful for applying a bolster material to a surgical fastening device such as a stapler, and related methods of manufacture and use. The devices include an applicator element for receipt between arms of the stapler, and a bolster material, desirably a remodelable extracellular matrix material, coupled to the applicator element. In certain embodiments, the bolster material is held by the applicator element, for example having at least a portion looped around or received through or over a portion of the applicator element. Also described are unique implantable materials including coatings of dried, reversible adhesive.

REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of InternationalApplication No. PCT/US2005/005501 filed Feb. 17, 2005 (which waspublished in English), which claims the benefit of U.S. patentapplication Ser. No. 60/545,513 filed Feb. 17, 2004, each of which ishereby incorporated by reference in its entirety.

BACKGROUND OF THE INVENTION

The present invention resides generally in the field of medicine and inparticular aspects to devices and methods that are useful for applying abolster material to a device for inserting surgical fasteners, e.g. asurgical stapler.

As further background, surgical stapler devices are designed to seal orsimultaneously cut and seal an extended segment of tissue in a patient.Some surgical staplers include two stapler arms, a first arm includingtwo or more lines of multiple staples (also called a “cartridge” or“jaw”) and a second arm including an anvil or other feature adapted tobend each of the staples into a closed position upon operation of thestapler. So-called “anastomotic” staplers include a surgical blade inthe device to sever tissue between the lines of staples. Those withoutsuch a cutting blade have been referred to as “non-anastomotic”staplers.

For some medical procedures, the use of bare staples, with the staplesin direct contact with the patient's tissue, is generally acceptable.The integrity of the patient's tissue itself will normally serve toprevent the staples from tearing out of the tissue and compromising theseam before healing has occurred. However, in other procedures, thepatient's tissue to be sealed is too fragile to securely hold thestaples in place. For example, in the case of lung tissue, and inparticular diseased lung tissue, the tissue to be stapled is fragileand, in extreme cases, will easily tear through unprotected staplelines. With the growing use of surgical staplers in operations ondiseased lung tissues such as bullectomies and volume reductionprocedures, it has become increasingly important to take measures toprotect fragile tissue from tissue tears due to surgical staples orsurgical stapling procedures.

One known protective measure involves the use of a reinforcement orbolster material, wherein the staples are inserted both through thebolster material and the patient's tissue. In many cases, as apreliminary step, the reinforcement material is in some manner appliedto the arms of the surgical stapler, e.g. with portions applied to eacharm, and the stapler thereafter used to secure tissue of the patient.The present invention provides medical devices and methods that areuseful for applying bolster material to surgical staplers or othersimilar surgical fastening devices.

SUMMARY OF THE INVENTION

In one aspect, the present invention provides a medical device usefulfor applying a bolster material to a surgical stapler or other similarsurgical fastening device, wherein the medical device includes anapplicator element and a bolster material coupled to one another. Thiscoupling can, for instance, be of such a nature that the bolstermaterial and the applicator element are retained in association with oneanother without other mechanical components.

In one embodiment, the present invention provides a medical deviceuseful for applying a bolster material to a surgical fastening devicehaving a first arm and a second arm presenting respective first andsecond opposed surfaces. The medical device of the invention includes anapplicator element having at least a first side, and one or more piecesof bolster material coupled to the applicator element and presented atthe first side of the applicator element. The bolster material can becoupled to the applicator element, for example, by portion(s) of thebolster material extending through and/or around the applicator element,and/or by bonding. The bolster material presented at the first side ofthe applicator element can be brought into contact with a first armsurface of the fastening device during a loading procedure. In certainembodiments, bolster material is presented at both first and secondsides of the applicator element, for application to both first andsecond arm surfaces of the fastening device. Illustratively, the opposedarm surfaces of a device such as a surgical stapler can be closed arounda medical device of the invention so as to cause adherent contact of thearm surfaces with the bolster material. The coupling between the bolstermaterial and the applicator element can be eliminated, so that theapplicator element can be separated from the bolster material contactingthe arm surfaces, to leave bolster material on the surfaces when thearms are separated. The applicator element can then, if desired, bedisposed of. Additional embodiments of the invention relate to methodsof manufacture and of use of devices such as those described above, aswell as inventive applicator elements and bolster material constructsused in such devices.

In another embodiment, the invention provides a bolster device thatincludes a bolster material configured for application to an arm of asurgical fastening device, and a dried, reversible adhesive coating onsaid bolster material.

In still another embodiment, the invention provide a medical device, forexample a bolster device, that includes a layer of dried, collagenousextracellular matrix (ECM) material, and a dried, reversible adhesivecoating on the layer of ECM material.

Additional embodiments as well as features and advantages of theinvention will be apparent from the further descriptions herein.

DESCRIPTION OF THE FIGURES

FIG. 1 provides a front view of an applicator element of the invention.

FIG. 2 provides a front view of a bolster material construct of theinvention.

FIG. 3 provides a front view of a medical device of the inventionincluding the applicator element and bolster material construct of FIGS.1 and 2, respectively.

FIG. 4 provides a right end view of the medical device of FIG. 3.

FIG. 5 provides a front view of another applicator element of and foruse in the invention.

FIG. 5A, 5B and 5C provide bottom end views of the applicator element ofFIG. 5 with elements 35 and 36 both folded up (FIG. 5A) or both foldeddown (FIG. 5B), or with one up and one down (FIG. 5C).

FIG. 6 provides a front view of another medical device of the inventionuseful for applying a bolster material.

FIG. 7 provides a cross-sectional view of the device of FIG. 6.

FIGS. 8-11 provide front views of additional medical devices (FIGS. 8and 11) of the invention and bolster material constructs (FIGS. 9 and10) that can be incorporated therein.

FIG. 12 provides a front view of another applicator element of theinvention.

FIG. 13 provides a front view of another medical device of the inventionincorporating the applicator element of FIG. 12.

FIG. 14 provides a cross-sectional view of the device of FIG. 13 takenalong line 14-14 and viewed in the direction of the arrows.

FIGS. 15-17 provide front views of another medical device of theinvention (FIG. 17) and applicator element (FIG. 15) and bolstermaterial construct (FIG. 16) components thereof.

FIGS. 18-19 a side view and a front view of another medical device ofthe invention, respectively.

FIGS. 20-21 provide a side view and a front view of view of anothermedical device of the invention, respectively.

FIGS. 22 and 23 provide a side view and a front view of another medicaldevice of the invention, respectively.

FIGS. 24 and 25 provide a side view and a front view of another medicaldevice of the invention, respectively.

FIGS. 26 and 27 provide side and front views of another medical deviceof the invention, respectively.

FIGS. 28-30 illustrate another medical device of the invention andcomponents thereof. FIGS. 28 and 30 provide front views of an applicatorelement and bolster material constructs, respectively. FIG. 29A providesa front view of a medical device assembled from the components of FIGS.28 and 30. FIG. 29B provides a rear view of the device of FIG. 29A.

FIGS. 31-33 illustrate another medical device of the invention andcomponents thereof. FIGS. 31 and 33 provide front views of an applicatorelement and bolster material constructs, respectively. FIG. 32A providesa front view of a medical device assembled from the components of FIGS.31 and 33. FIG. 32B provides a rear view of the device of FIG. 32A.

FIGS. 34 and 35 provide front views illustrating another medical deviceof the invention and components thereof.

FIGS. 36-38 illustrate another medical device of the invention andcomponents thereof. FIGS. 36 and 37 provide side views of a bolstermaterial loop and applicator element, respectively. FIGS. 38A and 38Bprovide side and front views, respectively, of a medical deviceassembled from the components depicted in FIGS. 36 and 37.

FIGS. 39-42 illustrate another medical device of the invention andcomponents thereof.

FIGS. 100-104 depict steps in an inventive method for applying a bolstermaterial to a surgical stapler.

DETAILED DESCRIPTION

For the purposes of promoting an understanding of the principles of theinvention, reference will now be made to the embodiments illustrated inthe drawings and specific language will be used to describe the same. Itwill nevertheless be understood that no limitation of the scope of theinvention is thereby intended, and alterations and modifications in theillustrated device, and further applications of the principles of theinvention as illustrated therein are herein contemplated as wouldnormally occur to one skilled in the art to which the invention relates.

As disclosed above, the present invention provides medical articlesuseful for applying a bolster material to a surgical fastening devicesuch as a surgical stapler, and related methods. In this regard, aspectsof the present invention are at times described herein in connectionwith a surgical stapling device. While this represents an embodiment ofthe invention, it will be understood that the bolstering devices of theinvention may be used in conjunction with a variety of surgicalfastening devices that insert fasteners of various designs, includingfor example one-part and multiple (e.g. two) part staples, tacks, orother penetrating fasteners where bolstering may provide a benefit.

With reference now to FIG. 1, shown as a plan view of an applicatorelement 11 of and useful in the present invention. Applicator element 11includes a body 12 to be used in conjunction with a staple bolstermaterial. Body 12 is desirably formed all or in part of a compressiblematerial, for example a polymer foam. Body 12 may, for example, be madefrom Styrofoam or another similar material. It will be understood,however, that body 12 can be made of any suitable material.

The illustrated body 12 generally includes a first rectangular portion13 for accommodating a strip of staple bolster material, the rectangularportion 13 terminating in a generally wider portion including a firstlaterally extending portion 14 and a second laterally extending portion15. Laterally extending portions 14 and 15 can, for instance, provide asegment of material that will extend laterally from the arms of asurgical stapler closed around applicator element 11. In this fashion, auser may grip portions 14 and 15 before and during the loadingprocedure. Lateral portion 14 is defined by first edge portion 16extending transversely from the outside edge of generally rectangularportion 13. Edge 16 may form an angle greater than, less than, or equalto 90° relative to the outer edge of rectangular portion 13. Desirably,as illustrated, edge 16 forms a generally obtuse angle relative to theouter edge of rectangular portion 13. Lateral portion 14 is bounded byouter edge 17 which, as shown, is generally parallel the outer edge ofthe rectangular portion 13, although any other suitable relationship iscontemplated. Lateral element 14 as illustrated also includes a thirdedge 18 which as shown is generally perpendicular to the outer edge ofrectangular portion 13. The illustrated applicator element 11 includes acorresponding and opposed lateral element 15 defined by edge 19, 20, and21 that are similar to edges 16, 17, and 18, respectively. It will beunderstood that in embodiments of the present invention includinglateral extensions, the configuration of the lateral extension may takeany form suitable to provide a segment to provide a user grip. Forexample, lateral extensions may be formed as generally triangularsections, rectangular sections, or circular segments, e.g. semi-circularportions, extending laterally of the rectangular portion 13. Applicatorelement 11 also includes an engaging end 22 for engaging a staplebolster material. Engaging end 22 desirably forms a shoulder at anintersection with a wider portion of applicator element 11, for exampleincluding a width W1 generally less than that of the adjacent portionincluding lateral extensions 14 and 15, optionally with width W1 beingless than or about equal to width W2 of the rectangular portion 13,although this is not necessary to the broader aspects of the presentinvention.

With reference now to FIG. 2, shown is an inventive strip of staplebolster material 23 that can be used in conjunction with applicatorelement 11 of FIG. 1. Staple bolster strip 23 includes a generallyelongate body 24 having a first opening 25 and a second opening 26defined adjacent opposed ends thereof. Openings 25 and 26 can be of anysuitable size and dimension, including slits, apertures, or otheropenings suitable for use in conjunction with cooperating engagingportions of applicator elements. Staple bolster strip 23 as shown isgenerally rectangular in its external shape including first elongateedge 27, second elongate edge 28, and end edges 29 and 30 extendinggenerally perpendicular thereto. Staple bolster strip 23 can be madefrom any suitable material to bolster a staple line or single staple,including those materials described hereinbelow.

With reference now to FIG. 3, shown is an assembled medical device 31useful for applying a staple bolster material to a surgical stapler,having staple bolster strip 23 coupled to applicator element 11. Inparticular, in one mode of assembly, engaging portion 22 of applicatorelement 11 can be inserted through aperture 26 adjacent to end 30 of thestaple bolster strip 23. Staple bolster strip 23 can then be extendeddown and around generally rectangular portion 13 so as to encompass bothsides thereof. Applicator element 11 can then be deformed as necessaryto insert the engaging portion 22 through aperture 25 adjacent end 29.This will provide an arrangement as illustrated, in which the staplebolster strip 23 is wrapped around element 11 and secured thereto withthe help of engaging portion 22 which extends through apertures 25 and26 of staple bolster strip 23. With reference to FIG. 4, shown is aright-end view of the medical device 31 of FIG. 3. As shown, staplebolster strip 23 is wrapped around applicator element 11, with theengaging portion 22 extending through apertures 25 and 26.

With reference now to FIGS. 1-4 together with FIGS. 100-104, anillustrative manner of using the medical device 31 in conjunction with asurgical stapler 200 will be described. With the arms 201 and 202 of thesurgical stapler in an open condition (see FIG. 100), the assembledmedical device 31 can be inserted between the arms of the surgicalstapler 200 so as to align the staple bolster strip 23 with the opposedsurfaces of the respective arms. The arms are closed around the medicaldevice 31 so as to bring the opposed surfaces in contact with the staplebolster strip 23 on opposite sides thereof, as shown in FIG. 101. Staplebolster strip 23 is caused to adhere to the stapler arm surfaces,optionally with the assistance of a sticking agent. With the arms in theclosed condition, the engaging portion 22 can be separated from theremainder of the applicator element 11 so as to cause a release of theends 29 and 30 of the staple bolster strip 23, as shown in FIG. 102. Asexamples, the separation of the engaging portion 22 can be caused bytearing or cutting. After the separation of the engaging portion andrelease of the staple bolster ends 29 and 30, the arms 201 and 202 arecaused to separate, whereupon staple bolster strip 23 remains adhered toand is carried apart by the arm surfaces generally forming a “V”configuration conforming to that provided by the arm surfaces. In thisstate, the major portion of the applicator element will remain betweenthe arms 201 and 202 along with the staple bolster strip 23, asillustrated in FIG. 103. Applicator element 11 can then be removed fromthe surgical stapling device, leaving staple bolster strip 23 associatedwith the staple bolster device for use in reinforcing one or morestaples to be implanted using the surgical stapling device 200. Withreference generally to the above discussion, in another mode of use, theengaging portion 22 can be deformed or otherwise manipulated so as to beremoved from the apertures 25 and 26 to disengage the ends 29 and 30from the applicator element 11. Otherwise, the application procedure canbe the same.

With reference to FIG. 5, shown is an alternative applicator element 11Afor use in medical devices of the invention. Applicator element 11A issimilar to applicator element 11 described above, except having aweakened portion 32 to facilitate a tear-away operation to removeengaging portion 22 and thereby release ends 29 and 30 of an associatedstaple bolster strip 23. Weakened portion 32 may include any suitablemeans for facilitating tearing or breaking along the area, including forexample perforations, scores, thinner portions, and the like. These andother adaptations for facilitating separation of the engaging portion 22will be recognized by the skilled artisan and are encompassed by thepresent invention. Further, applicator element 11A (as well asapplicator element 11) may have a slit or cut lines 33 and 34 providedat the intersection of lateral portions 14 and 15 and generallyrectangular portion 13, forming “dog ears” 35 and 36 which can be foldedup and/or down (including both up—see FIG. 5A, both down—see FIG. 5B, orone up and one down—see FIG. 5C) to provide laterally-positioned nibs orsimilar members for limiting side-to-side sliding of bolster material(e.g. strip 23) associated with the applicator element. In addition oralternatively, the end of rectangular portion 13 on applicator elements11,11A can be notched (e.g. by cutting along line 37) to leave lateralpieces 38 and 39. With bolster strip 33 received around such end andwithin the notch, lateral pieces 38 and 39 can serve to limitside-to-side sliding of the bolster material. It will be understood thata similar end-notching approach could be used on both ends of applicatorelements 11,11A and at one or both ends of other overall applicatorelement shapes, including those disclosed herein.

With reference to FIG. 6, shown is another medical device 40 of theinvention that is useful for loading a staple bolster material on asurgical stapling device. Medical device 40 includes an applicatorelement 41 that has a generally rectangular portion 42 terminating in awider portion including a first laterally extending portion 43 and asecond laterally extending portion 44, similar to those found inapplicator element 11 of FIG. 1. Applicator element 41, however, isdevoid of the engaging portion 22 shown for applicator element 11 ofFIG. 1. Instead, applicator element 41 terminates in a generallystraight edge connecting the outer edges of lateral portions 43 and 44.A strip of staple bolster material 45 is associated upon applicatorelement 41. In the illustrated device, this is accomplished by loopingthe strip 45 around the applicator element 41, and adhering juxtaposedsurfaces of the strip to one another in the area 46 so as to stablyengage staple bolster strip 45 around application element 41. Thisadherence can be achieved by any suitable means, including bondingagents, cross-linking, glues, or other substances or mechanisms. Device40 may also include a weakened, tearable portion 47 provided in thebolster material, for example, by perforations, score marks, thinnerwall sections, or the like, as discussed above.

FIG. 7 provides a cross-sectional view of device 40 showing staplebolster strip 45 looped completely around and secured to applicatorelement 41, with the opposed segments of the bolster strip 45 adhered toone another in the area 46. In use, medical article 40 can be grippedeither in area 46 or by lateral portions 43 and/or 44, and insertedbetween the arms of a surgical stapling device as generally discussedabove. The arms can be closed around device 40, and the bolster strip 45can be torn along line 47 so as to create two free ends of the bolstermaterial 45. The arms of the stapling device can then be separatedthereby carrying with them respective segments of the staple bolstermaterial 45, and applicator element 41 removed to leave the loadedsurgical stapler.

With reference now to FIG. 8, shown is another medical device 50 of theinvention useful for applying a staple bolster material to the surgicalstapler. Medical device 50 includes an applicator element 51 similar toelement 41 described above, including a generally rectangular portion52, and lateral portions 53 and 54. Medical device 50 includes a staplebolster strip 55 wrapped around applicator element 51 and securedthereupon. With reference to FIGS. 8 and 9 together, staple bolsterstrip 55 is secured around applicator element 51 with a slot and tabcombination. In particular, staple bolster strip 55 includes a slot 56,and a tab 57 connected to the main body of strip 55 by a relativelynarrower portion 58. In use, strip 55 is secured around applicatorelement 51 by folding or otherwise deforming and inserting tab 57through slot 56, so as to create a secure loop of material aroundapplicator element 51. In use, device 50 can be grasped by a user atlateral portions 53 and/or 54, and/or in areas of the strip 55 extendingbeyond applicator element 51, e.g. near tab 57. Thus grasped, device 50can be inserted between arms of a stapler generally as discussed above,the arms closed around device 50, and tab 57 pushed back through slot 56so as to release the strip 55 from the applicator element 51.Thereafter, the arms can be separated and applicator element 51 removedto leave the loaded surgical stapler device. Alternatively, the staplebolster strip 55 can be torn, for example in areas occurring adjacentslot 56 and in narrower portion 58, to release the staple bolster strip55 from the applicator element 51. This tearing operation can occurwhile the arms are closed around device 50. Thereafter, the arms can beseparated, the applicator removed, thus again leaving the loadedsurgical stapler.

Further in this regard, shown in FIG. 10 is an alternative staplebolster strip 55A including an aperture 56A and a tab 57A similar tothose in strip 55 shown in FIG. 9. However, staple bolster strip 55Aalso includes weakened portions such as perforations 59A and 59Boccurring adjacent slot 56A and tab 57A, respectively. Theseperforations or other weakened portions can serve to provide a locationfor more predictably separating strip 55A to release the same from theapplicator element in operations such as those discussed above.

With reference now to FIG. 11, shown is another medical device 60 of theinvention. Device 60 is similar to device 50 shown in FIG. 8, exceptapplicator element 62 lacks the lateral portions found on element 51.Thus, device 60 includes a generally rectangular applicator element 61having a first end 62 and a second end 63 around which the staplebolster strip 55 (or 55A) can be secured.

FIGS. 12-14 illustrate another medical device 70 of the invention. Shownin FIG. 12 is applicator element 71 including a generally rectangularportion 72 terminating in a generally wider portion providing laterallyextending portions 73 and 74. Applicator 71 includes slots 75 and 76which are useful for receiving and securing a staple bolster strip.Slots 75 and 76 are separated by an intermediate portion 77. Withreference now especially to FIGS. 13 and 14, medical device 70 includesa staple bolster strip 80 wrapped around and secured by applicatorelement 71. In particular, the strip 80 is wrapped around the lower endof element 71 and is secured to applicator element using slots 75 and76. As shown, this can be achieved by threading a segment 81 of bolsterstrip 80 (front segment, FIG. 13) through aperture 76, aroundintermediate portion 77, and back through aperture 75. Another segment82 of bolster strip 80 can be threaded overtop segment 81 and throughaperture 75. In this manner, the end 83 of segment 81 and the end 84 ofsegment 82 will both occur on the same side of element 71 (front side,as illustrated) and the bolster strip 80 will thereby be secured to theapplicator element 71 in somewhat of a “belt buckle” fashion. In use,the device 70 can be compressed between arms of a surgical stapler asdescribed for devices hereinabove, to bring the bolster strip 80 intoadherent contact with the opposed arm surfaces. Thereafter, the ends 83and 84 of bolster strip 80 can be manually forced out of engagement withapertures 75 and 76, and the arms separated and the applicator element71 removed. Alternatively, with continuing light compression between thearms, the applicator element 71 may be slipped from in between the arms,thus leaving in place the bolster strip 80. Still further, withcontinuing reference to FIGS. 12-14, applicator element 71 can beprovided with perforations, a score, or another weakened area 78, and/orbolster strip 80 can be provided with similar weakened areas 85, suchthat while compressed between the arms, the applicator element 71 and/orbolster material 80 can be separated (e.g. torn) along the weakened areato disengage the bolster strip 80 from the element 71, whereafter thearms can be separated and the remainder of element 71 removed to providethe loaded stapling device.

FIGS. 15-17 illustrate another medical device 90 of the invention.Device 90 includes an applicator element 91 having a generallyrectangular portion 92 and a pair of slits 93 and 94 therein. Slits 93and 94 extend inwardly from opposed sides of applicator element 91, andextend partially across its width. Staple bolster strip 95 includes acentral portion 96, a first leg 97 and a second leg 98. As illustrated,bolster strip 95 can be wrapped around applicator element 91, and eachleg 97 and 98 threaded through its corresponding slit 93 and 94 to theopposite side of the element 91. In this fashion, bolster strip 95 canbe held in association with applicator element 91. Device 90 can be usedin fashions similar to those described for device 70 above, includingfor example the provision of appropriate weakened portions on theapplicator element 91 and/or bolster strip 95 for a separation feature.

With reference to FIGS. 18 and 19, shown is still another embodiment tothe invention. Shown is device 100 including an applicator element 101and associated therewith a bolster strip 102. Applicator element 101 isa dual-layer element including layers 103 and 104, which can be createdfor example by folding a single piece, e.g. at fold line 105. Theapplicator element 101 includes a leg 106 extending transversely fromlayer 104 and a leg 107 extending transversely from leg 106.Corresponding structures 108 and 109 extend from layer 103. In thisfashion, a “U”-shaped pocket is created for receiving end portions 110and 111 of bolster strip 102 to facilitate holding bolster strip 102 inassociation with applicator element when wrapped therearound. As withother devices described herein, the applicator element 101 canoptionally include a weakened portion 112, and/or the bolster strip 102can optionally include a weakened portion 113.

FIGS. 20 and 21 illustrate another embodiment of the invention. Shown isdevice 110 including applicator element 111 and a strip of bolstermaterial 112. Again, bolster strip 112 is generally wrapped aroundelement 111. In device 110, bolster strip 112 is held in associationwith element 111 through the use of raised pegs 113 and 114 ofapplicator element 111, which cooperate with corresponding apertures 115and 116 in bolster strip 112. Pegs 113 and 114 fit snugly into apertures115 and 116 thereby securing bolster strip 112 in association applicatorelement 111. Again, perforations or other weakened areas 117 and 118 canbe provided in applicator element 111 and bolster strip 112,respectively.

With reference now to FIGS. 22 and 23, shown is another embodiment ofthe invention, in which device 120 includes a generally rectangularapplicator 121 and secured therearound a bolster strip 122. Bolsterstrip 122 is secured in association with applicator element 121 throughthe use of glue, adhesive, or another bonding agent in areas such asthose found at 123 and 124 on each side of the applicator element 121.Perforations, scores, or other weakened areas 125 and 126 can beprovided in the bolster strip 122 and applicator element 121, tofacilitate a tear away or other separation operation as discussed above.

Shown in FIGS. 24 and 25 is another embodiment of the invention, inwhich device 130 includes applicator element 131 in a bolster strip 132.In the illustrated device 130, bolster strip 132 includes portionsextending beyond element 131, which are folded back at locations 133 and134, with the ends 135 and 136 of the bolster material 132 being securedto the applicator element 131 by any suitable bonding or otherattachment method. Bolster strip 132 can be provided with a weakenedarea 137 extending through all layers of bolster material at thatlocation. In this fashion, with the device 130 compressed between thearms of a surgical stapler, bolster strip 132 can be torn along line 137so as to release two free ends thereof and disengage the bolster strip132 from the applicator element 131. After the opposed arms areseparated with bolster material 132 remaining in adherent contacttherewith, both the portions of the bolster strip 132 torn away andthose remaining attached to the applicator element 131 can be disposed,leaving the loaded stapling device. Alternatively, device 130 can lackany perforations or other weakened areas, for example when the bolstermaterial is tearable in and of itself, or can be cut with a suitableinstrument to loose the free ends as discussed above.

With reference to FIGS. 26 and 27, shown is another embodiment of theinvention. Device 140 includes an applicator element 141 and itsassociated bolster strip 142. Applicator element 141 includes two layers143 and 144, which can be formed by folding a single piece, e.g. atlocation 145. Bolster strip 142 in device 140 includes overhangingportions and fold lines 146 and 147, generally corresponding to featuresfound in device 130 described above. However, in device 140, the ends ofbolster strip 142 are not adhered to the outer surface of element 141,but are rather tucked in between the two layers thereof to secure thesame. Suitable bonding or other attachment means can be used tofacilitate retaining the ends of bolster strip 142 between the layers143 and 144 can be used if desired or necessary. Bolster strip 142 caninclude a weakened area 148 extending through all layers at thelocation, to facilitate a tearing operation as described above.Alternatively, as discussed above, bolster strip 142 can lack any suchweakened area if the bolster material is itself tearable or can be cutwith a suitable instrument to provide free ends of bolster material anddisengagement of the bolster material 142 from the applicator element141.

FIGS. 28-30 show another embodiment of the invention. Device 150includes an applicator element 151, a first piece of bolster material152 and a second piece of bolster material 153. Applicator element 151includes flaps 154, 155, 156, and 157 defined by adjacent slits in thematerial forming applicator element 151. Bolster pieces 152 and 153include corresponding portions 154 prime, 155 prime, 156 prime, and 157prime, which can have segments tucked behind flaps 154-157 so as to holdthe bolster pieces 152 and 153 to opposed sides of applicator element151, as shown. As in other embodiments, device 150 can optionallyinclude score lines or other weakened areas providing tear lines in oneor more of the applicator element and bolster pieces as represented by158, 158 a, and 158 b. The device 150 is generally used as our devicesdiscussed above to load the surfaces of a surgical stapler with thebolster material. In this regard, the portions 154′, 155′, 156′, and157′, can be untucked prior to inserting a device between the staplerarms, if desired. Alternatively, applicator element 151 can be pulledout of the stapler while maintaining gentle compression on device 150with the stapler arms, to leave bolster pieces 152 and 153 positioned onthe stapler arms. For these purposes, the surface of the applicatorelement 151 can have a sufficiently low coefficient of friction for theapplicator removal procedure while leaving the bolster material on thestapler arms, either provided by the material from which element 151 ismade, or by relatively lower friction coatings or layers bonded thereto.

With reference to FIGS. 31-33, shown is another embodiment of theinvention that is similar to that shown in FIGS. 28-30. However, device160 of FIGS. 31-33 lacks lower end flaps corresponding to those of 156and 157. In this matter, the leading ends of bolster pieces 162 and 163for insertion into the stapler can either be uncoupled to applicatorelement 161, or can be coupled to the applicator element in other ways.Otherwise, device 160 has elements corresponding to those of device 150,including tucked portions 164′ and 165′, flaps 164 and 165, and optionaltear lines denoted by 166, 166A, and 166B.

Another embodiment of the invention is shown in FIG. 34 and FIG. 35. Inthis embodiment, device 170 includes an applicator element 171 havingfeatures corresponding to those of applicator element 12 of FIG. 1.Device 170 includes a piece of bolster material 172 is provided, havingloops 173 and 174 formed by suture material or any other suitablematerial attached near the ends of material 172. Bolster material 172 iscoupled to applicator element 171 in a fashion analogous to that shownand described for device 31 of FIGS. 3 and 4, except attached loops 173and 174 are received over engaging end 177 of applicator element 171.Also, perforation, score or other tear lines 175 and/or 176 can beprovided adjacent ends of bolster piece 172 if desired. The use ofdevice 170 can be analogous to that for device 31, with the usergripping and tearing away engaging portion 177 and optionally also loops173 and 174; and, where tear lines 175 and 176 are incorporated, alsotearing away end portions of bolster piece 172.

FIGS. 36-38 show another illustrative embodiment of the invention.Device 180 includes applicator element 181 in bolster material 182.Bolster material 182, as shown, is provided as a closed loop ofmaterial. In this regard, the bolster material may be manufactured orisolated as a tubular or closed loop material, or may be created from asheet of material by forming the sheet into a loop and attaching theends together, e.g. connected in either an end-to-end fashion or anoverlapping fashion. When creating a loop out of an ECM or othercollagenous material, the loop can be formed from a sheet that is loopedand overlapped onto itself, with the overlapped regions bonded to oneanother. This bonding may be achieved all or in part by dehydrothermallybonding the layers together, for example under conditions oflyophilization as discussed elsewhere herein. Bolster material 182 inloop form is sized relative to applicator element 181 so that receipt ofbolster material 182 around element 181 effectively holds the material182 to the element 181. Illustratively, loop 182 can be received aroundelement 181 under some level of tension retaining an effectiveassociation of the bolster material 182 with the applicator element 181.As in other embodiments, a tear line, represented at 183, can beprovided through the bolster material and/or the applicator element, ifdesired.

FIGS. 39-42 illustrate another embodiment of the invention, in whichdevice 190 includes an applicator element 191 similar in many respectsto element 71 of FIGS. 12-14. However, element 191 is adapted for moreconvenient receipt of separate bolster pieces on opposed sides ofelement 191. In this regard, a series of three (3) openings (e.g. slitsor slots) 194A, 194B, and 194C are provided at a first end, and anotherseries of three (3) openings 195A, 195B, and 195C, is provided atanother end of element 191. Separate bolster pieces 192 and 193, whichmay be made of the same or different material from one another, arereceived on the applicator element 191. This is achieved in theillustrated embodiment by capturing each end of each bolster piece inthe “belt buckle” fashion, as shown, by weaving the pieces through theopenings. In the illustrative embodiment, this will involve overlappingportions of bolster pieces 192 and 193 as best shown in FIG. 42, whichprovides a cross-sectional view taken along line 42-42 of FIG. 40B andviewed in the direction of the arrows. It will be understood that ifdesired, overlapped portions of bolster pieces 192 and 193 could beavoided in a similar attachment mechanism by including one or moreadditional openings at each end of the applicator element 191 so thateach end of pieces 192 and 193 could be woven through at least two slotsunoccupied by the other. As other embodiments disclosed herein, optionalscore lines 196, 196A, and 196B can be provided in the applicatorelement 191 and/or bolster pieces 192 and 193. Again, as with otherembodiments described herein, bolster pieces 192 and 193 could bedisengaged from applicator element 191 prior to insertion between thestapler arms, and/or by an operation including gentle compression ofdevice 190 between the stapler arms and sliding applicator element 191out therefrom.

It will be understood that in medical devices of the invention, onepiece, or more than one piece of staple bolster material, can be coupledto an applicator element, and bolster material may be presented at oneor both sides of the applicator element. For example, separate pieces ofstaple bolster material can be presented on the separate sides of theapplicator element as in some of the illustrated embodiments. Each pieceof bolster material can be held in association with the applicatorelement using any of the disclosed features, for example being bonded toor retained by the applicator element by having a least a portionthereof received around, through, over, etc., the applicator element.All such embodiments are contemplated as a part of the presentinvention. Advantageously, although not necessary to the broader aspectsof the invention, in certain embodiments, the bolster material will beretained in association with the applicator element without the use ofany other mechanical component (e.g. a clip) compressing or otherwiseholding the bolster material in contact with the applicator element.Thus, a bolster applicator device consisting of, or consistingessentially of, the applicator element and bolster material may bepresented between the arms of the surgical stapler for the bolsterloading operation.

Turning now to a discussion of the bolster material, any suitablebiocompatible material can be used in the broader aspects of theinvention. Reconstituted or naturally-derived collagenous bolstermaterials are desirable, especially collagenous extracellular matrixmaterials, such as submucosa, renal capsule membrane, dura mater,pericardium, serosa, peritoneum, dermal collagen, or basement membrane.The preferred bolster materials of the invention will include submucosa,such as submucosa derived from a warm-blooded vertebrate. Mammaliansubmucosa materials retaining substantially their native cross-linkingare preferred, although additionally crosslinked materials may also beused. In particular, extracellular matrix materials derived from animalsraised for meat or other product production, e.g. pigs, cattle or sheep,will be advantageous. Porcine submucosa provides a particularlypreferred material for use in the present invention.

The submucosa can be derived from any suitable organ or other biologicalstructure, including for example submucosa derived from the alimentary,respiratory, intestinal, urinary or genital tracts of warm-bloodedvertebrates. Submucosa useful in the present invention can be obtainedby harvesting such tissue sources and delaminating the submucosa fromsmooth muscle layers, mucosal layers, and/or other layers occurring inthe tissue source. For additional information as to submucosa useful inthe present invention, and its isolation and treatment, reference can bemade, for example, to U.S. Pat. Nos. 4,902,508, 5,554,389, 5,993,844,6,206,931, and 6,099,567.

When a submucosa or other ECM material having differing characteristicsides is used in the invention, it can be oriented upon the medicaldevice with a specified side directed outward for contact with thearm(s) of the surgical fastening device. For example, in the case ofsmall intestinal submucosa, the material may be oriented with either theluminal or abluminal side facing outwardly for contact with the arm(s)of the surgical fastening device.

As prepared, an extracellular matrix (ECM) material for use in thepresent invention may optionally retain growth factors or otherbioactive components native to the source tissue. For example, thematrix material may include one or more growth factors such as basicfibroblast growth factor (FGF-2), transforming growth factor beta(TGF-beta), epidermal growth factor (EGF), and/or platelet derivedgrowth factor (PDGF). As well, submucosa or other ECM material of theinvention may include other biological materials such as heparin,heparin sulfate, hyaluronic acid, fibronectin and the like. Thus,generally speaking, the ECM material may include a bioactive componentthat induces, directly or indirectly, a cellular response such as achange in cell morphology, proliferation, growth, protein or geneexpression. Further, in addition or as an alternative to the inclusionof such native bioactive components, non-native bioactive componentssuch as those synthetically produced by recombinant technology or othermethods, may be incorporated into the ECM material.

ECM material used in the invention is preferably highly purified, forexample, as described in U.S. Pat. No. 6,206,931. Thus, preferredmaterial will exhibit an endotoxin level of less than about 12 endotoxinunits (EU) per gram, more preferably less than about 5 EU per gram, andmost preferably less than about 1 EU per gram. As additionalpreferences, the ECM material may have a bioburden of less than about 1colony forming units (CFU) per gram, more preferably less than about 0.5CFU per gram. Fungus levels are desirably similarly low, for exampleless than about 1 CFU per gram, more preferably less than about 0.5 CFUper gram. Nucleic acid levels are preferably less than about 5 μg/mg,more preferably less than about 2 μg/mg, and virus levels are preferablyless than about 50 plate forming units (PFU) per gram, more preferablyless than about 5 PFU per gram. These and additional properties ofsubmucosa tissue taught in U.S. Pat. No. 6,206,931 may be characteristicof the ECM material used in the present invention.

Although not preferred, other implantable materials that may be employedas staple bolster materials in the present invention includenon-bioresorbable or bioresorbable synthetic polymer materials such aspolytetrofluroethylene (PTFE, e.g. GORE-TEX material), nylon,polypropylene, polyurethane, silicone, DACRON polymer, polyglycolic acid(PGA), polylactic acid (PLA), polycaprolactone, or others.

When a collagenous material is used as a staple bolster material in theinvention, it may be desirable to bond areas of the collagenous materialto one another, for example in securing the bolster material around allor a portion of an associated applicator element. Glues or other bondingagents may be used for this purpose, as discussed above. In addition oralternatively, collagenous material layers can be dehydrothermallybonded to one another, for example by drying the layers in contact withone another, e.g. under compression. The drying operation can, forexample, occur in a lyophilization (freeze drying) or vacuum pressingprocess.

In certain embodiments of the invention, the staple bolster materialwill have a thickness in the range of about 50 to about 1000 microns,more preferably about 100 to 600 microns, and most preferably about 100to about 350 microns. The staple bolster material will desirably providesufficient strength to effectively reinforce the staple(s), for exampleexhibiting a suture retention strength in the range of about 100 toabout 1000 gram force, e.g. typically in the range of about 200 to about600 gram force, each of these based upon 5-0 Prolene suture and a bitedepth of 2 mm. If necessary or desired, a multilaminate staple bolstermaterial can be used. For example, a plurality of (i.e. two or more)layers of collagenous material, for example submucosa-containing orother ECM material, can be bonded together to form a multilaminatestructure useful as a staple bolster material. Illustratively, two,three, four, five, six, seven, or eight or more collagenous layerscontaining submucosal or other collagenous ECM materials can be bondedtogether to provide a multilaminate collagenous bolster material. Incertain embodiments, two to six collagenous, submucosa-containing layersisolated from intestinal tissue of a warm-blooded vertebrate,particularly small intestinal tissue, are bonded together to provide thestaple bolster material. Porcine-derived small intestinal tissue ispreferred for this purpose. The layers of collagenous tissue can bebonded together in any suitable fashion, including dehydrothermalbonding under heated, non-heated or lyophilization conditions, usingadhesives, glues or other bonding agents, crosslinking with chemicalagents or radiation (including UV radiation), or any combination ofthese with each other or other suitable methods.

If needed, a sticking agent can be used to facilitate temporary adhesionof the staple bolster material to the arm surfaces. Any substance ormeans that increases the attachment of the bolster material to the armsurface can be used, so long as the attachment is not so permanent as todeleteriously interfere with release of the bolster material after thesurgical stapler has been fired or otherwise actuated to insert thestaple or staples. The substance can be inorganic, organic, natural orsynthetic. In many cases, biocompatible surgical lubricants will sufficeto improve this adhesion. Biocompatible adhesive materials, includingpressure-sensitive adhesives, may also be used , including for examplepolyvinyl pyrrolidones, polyvinyl alcohols, polyvinyl acetates, vinylacetate esters, starches, dextrins, acrylic resins, polyurethanes,styrene/butadiene radon copolymers, silicones, polyisobutylenes,polyisoprene polyvinyl ethyl ether and copolymers, blends orcombinations thereof. The adhesive can be applied to the bolsterreinforcement material at the point of use, or in a pre-appliedconfiguration. In certain embodiments, a pre-applied adhesive can becovered with release paper or similar material to protect the adhesivelayer during shipping and handling. The release paper can then beremoved prior to use.

Another aspect of the present invention provides an implantable deviceuseful as a staple bolster material. The implantable device includes adried, bioresorbable (and preferably bioremodelable) material havingcoated thereon a relatively thin layer of a dried, reversible adhesivesubstance. The bioresorbable material is preferably a collagenousmaterial, more preferably an ECM material as discussed hereinabove.Single or multilaminate ECM materials can be used, and multilaminatematerials including submucosal collagen are most preferred.

In certain inventive embodiments, the dried, reversible adhesive layeris non-tacky in the dried state, but becomes tacky when wetted withwater or an otherwise biocompatible aqueous solution such as saline. Inthis manner, a medical device containing the inventive implantablematerial, including but not limited to the medical devices disclosedhereinabove, can be packaged and shipped in a dried state, and thenwetted at the point of use (e.g. by attending medical personnel) torender the implantable material tacky. In the case of staple bolstermaterials, the material can then be adhered to the surgical stapler toprovide a buttress for a staple or staple line. Suitable reversible,water-activating adhesive substances include, for example, polyvinylpyrrolidones, polyvinyl alcohols, polyvinyl acetates, vinyl acetateesters, starches, dextrins, dextrans, sugars such as glucose, dextrose,and sucrose, carboxymethyl cellulose, carboxy methyl ethyl cellulose,hyaluronic acid, alginates, poly-lactides, gelatin, casein, polyethyleneglycol and other glycols, carbomer, glycerols or polymers, blends orcombinations thereof. Adhesive coatings including dextran, and inparticular dextran having an average molecular weight of about 70,000 orhigher, are preferred. The adhesive coating is desirably applied as arelatively thin layer, for example at a level of about 1 mg/cm² to about100 mg/cm² on the surface of the bolster material, although higher orlower levels may be used with a particular adhesive and/or bolstermaterials. In the case of dextran and similar polymers, a level of about4 mg/cm² to about 12 mg/cm² is preferred, although again higher or lowerlevels may be used in a particular circumstance.

The medical devices of the present invention can be used to facilitate avariety of surgical procedures. Such procedures include but are notlimited to various lung resection procedures (e.g., blebectomies,lobectomoies, bullectomies, wedge resections, and lung reductionprocedures, such as those used to treat symptoms of emphysema);treatment of soft tissue injuries and defects (e.g., abdominal orthoracic wall procedures, gastro-intestinal procedures), and as a toolin a variety of other surgical procedures (e.g., reproductive organrepair procedures, etc.). In this regard, the medical devices of theinvention may be used in conjunction with operations on both humans andanimals. Likewise, the medical devices of the invention may be used witheither anastomotic staplers or non-anastomotic staplers, and may beadapted, sized and shaped in a variety of ways to accommodate givenstapler devices.

The medical devices of the invention can be provided in sterilepackaging suitable for medical products. Sterilization may be achieved,for example, by irradiation, ethylene oxide gas, or any other suitablesterilization technique, and the materials and other properties of themedical packaging will be selected accordingly.

All publications cited herein are hereby incorporated herein byreference in their entirety as if each had been individuallyincorporated by reference and fully set forth.

While the invention has been illustrated and described in detail in thedrawings and foregoing description, the same is to be considered asillustrative and not restrictive in character, it being understood thatonly the preferred embodiment has been shown and described and that allchanges and modifications that come within the spirit of the inventionare desired to be protected.

What is claimed is:
 1. A medical device for applying a bolster materialto a surgical fastening apparatus having opposed arm surfaces,comprising: an applicator element for receipt between the opposed armsurfaces; and a closed loop of bolster material positioned around theapplicator element; wherein said closed loop of bolster material has awidth and a thickness, said width being greater than said thickness;wherein said closed loop of bolster material has a first surface thatextends across said width of said closed loop of bolster material andfaces said applicator element; wherein the applicator element iscomprised of a compressible material constructed and arranged to becompressed by the opposed arm surfaces of the surgical fasteningapparatus during application of the bolster material to the opposed armsurfaces; and wherein the bolster material comprises collagen.
 2. Themedical device of claim 1, wherein said bolster material is coupled tosaid applicator element by bonding with a bonding agent applied betweensaid bolster material and said applicator element.
 3. The medical deviceof claim 1, wherein the applicator element includes at least oneweakened area adapted for creating a separation in the applicatorelement.
 4. The medical device of claim 3, wherein the weakened area isa score in the applicator element.
 5. The medical device of claim 4,wherein the compressible material is a polymer foam.
 6. The medicaldevice of claim 1, wherein the applicator element is made of a materialsusceptible to manual tearing.
 7. The medical device of claim 1, whereinthe loop of bolster material includes at least one premanufactureddisruption point.
 8. The medical device of claim 7, wherein thepremanufactured disruption point includes first and second endsreleasably connected to one another.
 9. The medical device of claim 7,wherein the premanufactured disruption point includes a weakened portionof the bolster material.
 10. The medical device of claim 9, wherein theweakened portion includes perforations.
 11. The medical device of claim1, wherein said applicator element includes at least one lateral portionadapted for grasping when the applicator element is received between theopposed arm surfaces.
 12. A medical device for applying a bolstermaterial to a surgical fastening apparatus having opposed arm surfaces,comprising: an applicator element for receipt between the opposed armsurfaces; and a closed loop of bolster material positioned around theapplicator element; wherein said closed loop of bolster material has awidth and a thickness, said width being greater than said thickness;wherein said closed loop of bolster material has a first surface thatextends across said width of said closed loop of bolster material andfaces said applicator element; wherein the applicator element iscomprised of a compressible material constructed and arranged to becompressed by the opposed arm surfaces of the surgical fasteningapparatus during application of the bolster material to the opposed armsurfaces; and wherein the bolster material comprises an extracellularmatrix material.
 13. The medical device of claim 12, wherein theextracellular matrix material comprises submucosa.
 14. The medicaldevice of claim 13, wherein the submucosa is small intestinal submucosa.15. The medical device of claim 14, wherein the small intestinalsubmucosa is porcine.
 16. A medical device for applying a bolstermaterial to a surgical fastening apparatus having opposed arm surfaces,comprising: an applicator element for receipt between the opposed armsurfaces; and a closed loop of bolster material positioned around theapplicator element; wherein said closed loop of bolster material has awidth and a thickness, said width being greater than said thickness;wherein said closed loop of bolster material has a first surface thatextends across said width of said closed loop of bolster material andfaces said applicator element; wherein the applicator element iscomprised of a compressible material constructed and arranged to becompressed by the opposed arm surfaces of the surgical fasteningapparatus during application of the bolster material to the opposed armsurfaces; and wherein the applicator element includes a body portion andan engaging portion, wherein the engaging portion extends from the bodyportion, wherein the bolster material defines at least a first aperture,and wherein said engaging portion is received through said aperture. 17.The medical device of claim 16, wherein: said bolster material alsodefines at least a second aperture; said bolster material is wrappedaround said applicator element; and said engaging portion is receivedthrough said first aperture and said second aperture.